Table 2B Threshold Values for Human Health Chemical Hazard Endpoints
DRAFT- NOT FINAL (Dec, 2009)
Hazard
Very High (H)
High (H)
Moderate (M)
Low (L)
Carcinogenicity*
Recommended Test Methods and Models
· GHS Category 1A or 1B
· Authoritative and/or Screening Lists
· GHS Category 2
· Meets DfE General Screen Criteria for Carcinogenicity
Mutagenicity/Genotoxicity*
· Meets DfE General Screen Criteria for Genetic Toxicity
Reproductive/Developmental toxicity*
· GHS Category 2 or Effects on Lactation
· Meets DfE General Screen Criteria for Reproductive and Developmental Toxicity
Endocrine Disruption*
Recommended Test Methods and Models for Endocrine Mediated Effect (e.g. carcinogenicity, reproductive/developmental toxicity, repeated dose toxicity)
· Weight of evidence demonstrates possible endocrine system mediated effects and high potency
· Screening List
· Weight of evidence demonstrates possible endocrine system mediated effect that are lower potency and/or reversible effects
· Meets DfE General Screen for each endpoint related to an endocrine system mediated effect (e.g. carcinogenicity, reproductive/developmental toxicity, repeated dose toxicity)
Neurotoxicity*
· Weight of evidence demonstrates potential for irreversible neurotoxic effects in humans or developmental neurotoxicity in humans
· Weight of evidence demonstrates potential for neurotoxic effects in humans
· Meets DfE General Screen for Neurotoxicity
Acute Mammalian Toxicity (oral, dermal and inhalation)
· GHS Category 1 or 2
Authoritative and/or Screening Lists
· GHS Category 3
· GHS Category 4
· Meets DfE General Screen for Acute Mammalian Toxicity
Corrosion/Irritation of the Skin or Eye
· GHS Category 1 Skin
· GHS Category 1 Eye
· GHS Category 2 Skin
· GHS Category 2A Eye
· GHS Category 3 Skin
· GHS Category 2B Eye
· GHS not classifiable
Sensitization of the Skin or Respiratory System
Recommended Test Methods and Models for Skin Sensitization, Respiratory Sensitization
· GHS Category 1 Respiratory Sensitizer
· GHS Category 1A Skin Sensitizer
· GHS Category 1B Skin Sensitizer
· Meets DfE General Screen for Respiratory Sensitization and Skin Sensitization
Systemic Toxicity/Organ Effects (via single or repeated exposure, includes immunotoxicity)
Recommended Test Methods and Models for Single Exposure, Repeated Exposure, Immunotoxicity
· GHS Category 1 single exposure
· GHS Category 2 single exposure
· GHS Category 1 repeated exposure
· GHS Category 3 single exposure
· GHS Category 2 repeated exposure
· Meets DfE General Screen for Repeated Dose Toxicity. Must include evaluation of immune system effects.
· Not classifiable for GHS organ toxicity single exposure or repeated exposure.